Scientist, Pharmaceutical Science​/ Research, Research Scientist

Scientist, Attribute Sciences, Process Development

The Scientist, Attribute Sciences, Process Development develops, qualifies, and transfers phase-appropriate analytical methods supporting small molecule drug substance and drug product development from early clinical through commercial stages. The role collaborates closely with Process Development DS/DP teams to ensure methods are scientifically sound and compliant with regulatory requirements.

Education:

Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related scientific discipline with 1–3 years of industry experience; or M.S. with 4–6 years of relevant pharmaceutical industry experience; or B.S. with 6–8 years of relevant pharmaceutical industry experience.

Required Technical

Experience:

Hands-on experience with HPLC/UHPLC, GC, LC-MS, dissolution, KF, UV-Vis, FTIR, particle size, ICP-MS, and related analytical techniques. Strong knowledge of method development, qualification, validation, and transfer. Experience with impurity characterization, stability studies, and DS/DP development support.

Key Responsibilities:

• Develop, optimize, troubleshoot, and qualify analytical methods for characterization, release, stability, and process support.
• Develop stability-indicating methods for critical quality attributes, including assay, impurities, dissolution, water content.
• Support process development, optimization, technology transfer, and control strategy development.
• Characterize intermediates, starting materials, drug substances, and drug products.
• Build process understanding through impurity profiling and material characterization.
• Plan and execute method qualification and validation in accordance with ICH guidelines.
• Ensure methods are robust, reproducible, and fit for purpose across the product lifecycle.
• Analyze experimental data using sound scientific and statistical approaches.
• Maintain accurate documentation in ELNs and laboratory information systems.
• Author technical reports, development summaries, protocols, and presentations.